Medtronic Harmony Delivery Catheter System
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.
- Agency
- FDA Device
- Recall date
- May 22, 2026
- Status
- Ongoing
- Company
- Medtronic Heart Valves Division
1. What product was recalled?
Medtronic Harmony Delivery Catheter System
Medtronic Harmony Delivery Catheter System
Quantity: 1881 units
Code or lot text: GTIN 00763000341367, Lot Numbers: 0012508285, 0012517045, 0012526102, 0012526103, 0012614786, 0012614787, 0012623740, 0012623741, 0012642959, 0012659419, 0012663878, 0012663879, 0012690218, 0012699635, 0012702022, 0012710787, 0012728367, 0012728369, 0012777713, 0012804152, 0012804579, 0012824770, 0012824771, 0012874526, 0012896853, 0012896884, 0012910323, 0012965210, 0012965211, 0012976400, 0012986693, 0013063766, 0013063767, 0013105039, 0013105040, 0013133457, 0013181623, 0013181624, 0013236643, 0013272796, 0013272798. GTIN 00763000544027, Lot Numbers: 0012508285, 0012526103, 0012614786, 0012614787, 0012623740, 0012623741, 0012642959, 0012659419, 0012663879, 0012702022, 0012710787, 0012728367, 0012728369, 0012777713, 0012804152, 0012804579, 0012824771, 0012874526, 0012896853, 0012896884, 0012910323, 0012965211, 0012976400, 0012986693, 0013063767, 0013105039, 0013105040, 0013133457, 0013181623, 0013181624. GTIN 00763000520151, Lot Numbers: 0012575897, 0012642965, 0012728368, 0013272799. GTIN 00763000582951, Lot Numbers: 0012590535, 0012606411, 0012606413, 0012642964, 0012659418, 0012678282, 0012690219, 0012699637, 0012804151, 0012804580, 0012874527, 0012888682, 0012896885, 0012965221, 0012986699, 0013063764, 0013063765, 0013105037, 0013227504. GTIN 00763000918712, Lot Numbers: 0012635392, 0012676200, 0012690207, 0012874528, 0012874529, 0013015539, 0013105038.
- LOT
- 0012517045
- LOT
- 0012526102
- LOT
- 0012526103
- LOT
- 0012606411
- LOT
- 0012606413
- LOT
- 0012614786
- LOT
- 0012614787
- LOT
- 0012623740
- LOT
- 0012623741
- LOT
- 0012642959
- LOT
- 0012642964
- LOT
- 0012642965
- LOT
- 0012659418
- LOT
- 0012659419
- LOT
- 0012663878
- LOT
- 0012663879
- LOT
- 0012676200
- LOT
- 0012678282
- LOT
- 0012690207
- LOT
- 0012690218
- LOT
- 0012690219
- LOT
- 0012699635
- LOT
- 0012699637
- LOT
- 0012702022
- LOT
- 0012710787
- LOT
- 0012728367
- LOT
- 0012728368
- LOT
- 0012728369
- LOT
- 0012777713
- LOT
- 0012804151
- LOT
- 0012804152
- LOT
- 0012804579
- LOT
- 0012804580
- LOT
- 0012824770
- LOT
- 0012824771
- LOT
- 0012874526
- LOT
- 0012874527
- LOT
- 0012874528
- LOT
- 0012874529
- LOT
- 0012888682
- LOT
- 0012896853
- LOT
- 0012896884
- LOT
- 0012896885
- LOT
- 0012910323
- LOT
- 0012965210
- LOT
- 0012965211
- LOT
- 0012965221
- LOT
- 0012976400
- LOT
- 0012986693
- LOT
- 0012986699
- LOT
- 0013015539
- LOT
- 0013063764
- LOT
- 0013063765
- LOT
- 0013063766
- LOT
- 0013063767
- LOT
- 0013105037
- LOT
- 0013105038.
- LOT
- 0013105039
- LOT
- 0013105040
- LOT
- 0013133457
- LOT
- 0013181623
- LOT
- 0013181624
- LOT
- 0013181624. GTIN 00763000520151
- LOT
- 0013227504. GTIN 00763000918712
- LOT
- 0013236643
- LOT
- 0013272796
- LOT
- 0013272798. GTIN 00763000544027
- LOT
- 0013272799. GTIN 00763000582951
- LOT
- GTIN 00763000341367
- LOT
- Lot Numbers: 0012508285
- LOT
- Lot Numbers: 0012575897
- LOT
- Lot Numbers: 0012590535
- LOT
- Lot Numbers: 0012635392
- RECALL-NUMBER
- Z-2624-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
View source evidence for state distribution
- Puerto Rico: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Canada, Chile, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Mexico, Netherlands, Northern Ireland, Norway, Oman, Poland, Portugal, Puerto Rico, Qatar, Romania, Saudi Arabia, Spain, Sweden, Switzerland, Thailand, United Kingdom.
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. The Recall Guy's urgency label is urgent, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Device source
The Recall Guy normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.